Biological adhesive loading station and method

ABSTRACT

A loading station having a dispensing manifold for loading syringe pairs with thrombin and adhesive and clotting proteins for use as a biological adhesive. The resulting loaded syringe pairs are compatible with a variety of biological adhesive dispensers and may be used in a surgical setting.

FIELD OF THE INVENTION

[0001] The following invention relates generally to instrumentalitiesand methodologies in preparing and administering biological adhesives.More specifically, the instant invention is directed to a method andapparatus for simultaneously loading dispensing assemblies with multiplecomponents of biological glue and preparing the biological glue in amanner specific to the required need.

BACKGROUND OF THE INVENTION

[0002] This application represents applicant's ongoing efforts in thefield of collecting, preparing, and dispensing components of biologicaladhesives.

[0003] U.S. Pat. No. 5,759,171 discloses a sprayer for fibrin glueconfigured with a pistol grip, barrel, and trigger, and adapted to holdtwo syringes containing the fibrin glue components. Activation of thetrigger moves a plunger support, emptying the two syringes. Each syringecommunicates with an outlet having an atomizer, and the atomizers areoriented to form the fibrin glue away from the tip of the sprayer, toprevent clogging.

[0004] U.S. Pat. No. 5,975,367 is directed to a hand-held dispenser forfibrin glue. The dispenser includes a spring-based rack thatcommunicates with two syringes containing fibrin glue components suchthat the dispensed components may mix away from the tip of thedispenser. Drops or elongate lines of fibrin glue may be dispensed.

[0005] U.S. Pat. No. 6,077,447 reveals an apparatus, system and methodfor fractionating from whole blood, plasma, or other blood products theclotting factor known as fibrinogen, one component of a biologicaladhesive. A container is loaded with blood product containingfibrinogen, and the container is then put in registry with a heattransfer platen. The platen and container combination is rockedcontemporaneously with temperature changes that induce a phase change inthe blood product. The fibrinogen is then extracted from the containerfor subsequent use.

[0006] U.S. Pat. No. 6,274,090 B1 divulges an apparatus and method forpreparing thrombin, another component of a biological adhesive. Thethrombin component is extracted from donor plasma and converted tothrombin, while also removing contaminating proteins. Additionally, asystem is described in which thrombin and adhesive and clotting proteinsare simultaneously harvested from the same donor plasma, providing amore stable product than previously available. Both procedures occur inabout one hour in a sterile environment, and are thereby optimized foruse in a surgical setting.

[0007] WIPO application 00/74713A1 describes an improved thrombinprocessing unit that may be used with the methods revealed in U.S. Pat.No. 6,274,090 B1.

SUMMARY OF THE INVENTION

[0008] The present invention streamlines processing of thrombin andadhesive and clotting proteins to produce biological adhesives.Processing time is shorted, and the loading of syringes with thebiological adhesives may be accomplished with improved sterility, lesswaste and more expeditious and particularly safer handling (e.g., fromneedle sticks) than heretofore experienced.

[0009] The present invention especially enhances the economics andpracticalities of processing blood into biological adhesives.Customarily, a donor provides 500 mL (one “unit”) of whole blood. Thisunit, when processed, yields 250-300 mL of plasma, which results in twocomponents: 4.5-8.5 mL clotting proteins and about 8.5 mL of thrombin.Since the minimum quantum of biological adhesive needed comprises 1-2mL, and because each component comprises approximately 50 percent of thetwo-part adhesive, one unit of whole blood can generate approximately 4to 8 doses of biological adhesive. The instant invention loads andpackages biological adhesive in convenient doses.

[0010] Syringe pair assemblies are attached to a dispensing manifold ona loading station. Processing units for each component of the biologicaladhesive are mounted near the dispensing manifold, with dispensing linesrunning therebetween. Blood product is introduced into the separateprocessing units for the components for the adhesive. The desiredcomponent is extracted from the blood product. The components runthrough separate dispensing lines into syringes such that each syringepair contains one syringe loaded with each component. The syringe pairsare removed from the dispensing manifold, and may be utilized in avariety of ways when in actual use. The syringes are compatible with anadhesive spraying apparatus, and may also be used with a heating stationto maintain the adhesive components at an optimal temperature for use ina surgical setting.

OBJECTS OF THE INVENTION

[0011] Accordingly, it is a primary object of the present invention toprovide a new and novel device and method for loading multiple syringeswith biological glue components.

[0012] It is a further object of the present invention to provide adevice and method as characterized above in which the loading procedureis independent of the application for which the biological glue isutilized.

[0013] It is a further object of the present invention to provide adevice and method as characterized above which minimizes waste inloading the biological glue dispenser, improves efficiency and maintainssterility.

[0014] It is a further object of the present invention to provide adevice and method as characterized above that minimizes clogging of thedispenser in delivering the biological glue to the intended site.

[0015] It is a further object of the present invention to provide adevice and method as characterized above that may be utilized in asurgical setting.

[0016] Viewed from a first vantage point, it is an object of the presentinvention to provide an apparatus for collecting thrombin and clottingproteins, comprising, in combination: a first conduit operativelyconnected to a source of thrombin; and a second conduit operativelyconnected to a source of clotting proteins, each said conduitoperatively connected to a plurality of dispensing means.

[0017] Viewed from a second vantage point, it is an object of thepresent invention to provide a method for loading dispensing means withthrombin and clotting proteins, the steps including: attaching aplurality of said dispensing means to separate dispensing linescontaining thrombin and clotting proteins; manipulating said pluralityof dispensing means to purge air in each of said dispensing lines; andsequentially filling said plurality of dispensing means through each ofsaid dispensing lines.

[0018] These and other objects will be made manifest when consideringthe following detailed specification when taken in conjunction with theappended drawing figures.

BRIEF DESCRIPTION OF THE DRAWINGS

[0019]FIG. 1 is a perspective view of the loading station.

[0020]FIG. 2 is a side view of the dispensing manifold with attachedsyringes within their associated membranes.

[0021]FIG. 3 is a view of the dispensing manifold.

[0022]FIG. 4 is a view of the syringe pair assembly in its membrane inthe contracted position.

[0023]FIG. 5 is a view of the syringe pair assembly in its membrane inthe extended position.

[0024]FIG. 6 depicts the first step in a loading process, extending thesyringe pair assembly in the endmost position.

[0025]FIG. 7 depicts the second step in a loading process, contractingthe syringe pair assembly in the endmost position.

[0026]FIG. 8 depicts the third step in a loading process, filling thesyringe pair assembly closest to the support.

[0027]FIG. 9 depicts the fourth step in a loading process, filling thesyringe pair assembly second from the support.

[0028]FIG. 10 depicts the fifth step in a loading process, filling thesyringe pair assembly third from the support.

[0029]FIG. 11 depicts the sixth step in a loading process, filling thesyringe pair assembly fourth from the support.

[0030]FIG. 12 is a view of the syringe pair assembly in its contractedposition within its associated membrane.

[0031]FIG. 13A is a top view of a syringe pair assembly that may be usedwith the loading station of the present invention.

[0032]FIG. 13B is a bottom view of a syringe pair assembly that may beused with the loading station of the present invention.

[0033]FIG. 14 is a view of the syringe pair assembly in its extendedposition within its associated membrane.

[0034]FIG. 15 depicts a spraying apparatus for use with the syringe pairassembly of the present invention.

[0035]FIG. 16 depicts the spraying apparatus and a syringe pair assemblyhaving a first attachment.

[0036]FIG. 17 depicts the spraying apparatus and a syringe pair assemblyhaving a second attachment.

[0037]FIG. 18 depicts the spraying apparatus and a syringe pair assemblyhaving a third attachment.

[0038]FIG. 19 depicts the spraying apparatus and a syringe pair assemblyhaving a fourth attachment.

[0039]FIG. 20 is a top view of a syringe pair assembly having an outputcoupling and spray nozzle.

[0040]FIG. 21 is a bottom view of the syringe pair assembly having anoutput coupling and spray nozzle.

[0041]FIG. 22A is a perspective view of the output coupling.

[0042]FIG. 22B is a view along the section 22B-22B, depicting the outletpath of the contents of one syringe of the syringe pair assembly.

[0043]FIG. 22C is a view along the section 22C-22C, depicting the outletpath of the contents of the other syringe of the syringe pair assembly.

[0044]FIG. 23 is an exploded view of a nozzle attachment that may beassociated with the output coupling of the present invention.

[0045]FIG. 24 is a cutaway view of a nozzle attachment that may beassociated with the output coupling of the present invention.

[0046]FIG. 25 is an exploded view of attachments that may be associatedwith the output coupling of the present invention, one having a spraynozzle and the other having a helical mixing path.

[0047]FIGS. 26 and 27 are cutaway views of lengthening attachmentshaving helical mixing paths and spray nozzle ends that may be associatedwith the present invention.

[0048]FIG. 28 depicts a heating apparatus that receives the syringe pairassembly of the present invention, here used with the spraying apparatusof FIG. 15.

[0049]FIG. 29 depicts a heating apparatus that receives the syringe pairassembly of the present invention, here used with the assembly shown inFIGS. 20 and 21.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0050] Considering the drawings, wherein like reference numerals denotelike parts throughout the various drawing figures, reference numeral 10as shown in FIG. 1 is directed to the loading station according to thepresent invention.

[0051] In its essence, the loading station 10 includes a support 2, towhich the following are mounted: a thrombin processing unit 4, aclotting and adhesive proteins processing unit 6, and a dispensingmanifold 8. Each unit 4, 6 has a separate dispensing line 16 a, 16 b tothe dispensing manifold 8 as shown in FIG. 1, to maintain sequestrationof each component of the biological glue. The outlet 12 connected to thethrombin processing unit 4 leads into a reserve vessel 14, wherebypressure from a thrombin syringe 7 causes thrombin to enter the reservevessel 14. Rods 1 suspend support 2. Hooks 3 support the thrombinprocessing unit 4, the clotting and adhesive proteins processing unit 6,and reserve vessel 14. Clips 5 support the dispensing manifold 8. Thedispensing manifold 8 is preferably oriented to load a plurality ofsyringe pair assemblies 20 (FIG. 13B) with components of the biologicalglue. FIG. 2 depicts four such syringe pair assemblies 20, but it isalso observed from FIG. 2 that additional assemblies 20 may be present.

[0052] The syringe pair assembly 20 is pictured in FIGS. 13A, 13B. Theassembly 20 includes two syringes 22 a, 22 b; a barrel-holding frame 24;and a plunger connector 26. A fitting 18 is also present, the fitting 18adapted to frictionally hold the syringe pair assembly 20 together andlink to the dispensing manifold 8 via tubing 9. The barrel-holding frame24 includes a spring-based plastic retaining member 28; in FIG. 13B, theretaining member 28 secures the barrel-holding frame 24 to the fitting18. The spring 27 is shown as a resilient leaf (FIG. 13B) integral withframe 24 and leading to the retainer 28. The assembly 20 is housedinside a membrane 30, particularly during loading. The membrane 30 ispreferably flexible plastic, formed with a gathered (doubled-over)portion 32 about the assembly 20. The gathered portion 32 is formed bycreating pleats 36 using “accordion”-type folds in the membrane 30, witha first layer 30 a (FIG. 11) of the membrane 30 proximate the syringepair assembly 20 (FIGS. 4, 12) and an outer layer 30b which moves froman overlying position (relative to the first layer 30 a) to acoextensive position after loading a syringe pair assembly 20, one withclotting proteins and the other with thrombin. One end of the membrane30 is sealed over the tubing 9 that connects to the dispensing line 16a, 16 b via dispensing manifold 8. The other end of the membrane 30 isalso closed and is deployed about the syringe plungers 38 a, 38 b, toallow an operator to grasp and extend the plunger end during filling ofthe syringe pair assembly 20 without exposure to ambient conditions.Downward force, shown by the arrow A in FIG. 6, while grasping theplunger end and the membrane 30 allows the pleats 36 of the gatheredportion 32 to expand while always encasing the now-fully extendedassembly 20 (FIGS. 5, 14). The plunger end of the membrane 30 will beopened (FIG. 14) in an operatory to allow access to the filled syringepair assembly 20 during a surgical procedure. As shown in FIG. 14, afree end 37 of the membrane 30 shows the membrane as formed from theparts 37 a, 37 b, sealed together but separable (by peeling apart) toexpose plunger connector 26 of the loaded syringe pair. Thus, the loadedsyringe pair is maintained sterile until actual use in surgery.

[0053] The procedure for loading the assemblies 20 with thrombin andadhesive and clotting proteins is shown in FIGS. 6-11. Before loading,all assemblies 20 are encased in membranes 30 and attached to thedispensing manifold 8 using the fittings 18. The assembly 20 locatedfurthest from the end of the dispensing manifold 8 is preferably drawingon the dispensing lines 16 a, 16 b by extending the syringe plungers(FIG. 6) to fill the dispensing lines 16 a, 16 b and dispensing manifold8. It is then preferably returned to its original contracted position(FIG. 7) after having expelled excess air. Beginning from the oppositeend, each assembly 20 is successively extended to fill the syringebarrels 34 a, 34 b with the appropriate amounts of thrombin and clottingand adhesive proteins (FIGS. 8-11). After all assemblies 20 are loaded,each assembly 20 and its associated membrane 30 may then be removed fromthe dispensing manifold 8 by heat sealing or crimping tubing 9 andsevering at the crimp or heat seal, or upstream at the juncture 11 ofthe tubing 9 with the manifold 8.

[0054] To remove assembly 20 from membrane 30, spring 27 is depressedtoward syringes 22 a, 22 b to list retaining member 28 from mating catchon fitting 18. Syringes 22 a, 22 b are twisted and pulled away fromfitting 18, allowing assembly 20 to reside loose within membrane 30.Membrane 30 is then peeled apart, as described earlier, to removeassembly 20.

[0055] Once filled and removed, the assembly 20 may be fitted with anoutlet coupling 40, shown in FIG. 22A. The retaining member 28 latchesto a catch 42 on coupling 40 (FIG. 21). As shown in FIGS. 22B and 22C,the outlet coupling 40 equips each syringe 22 a, 22 b with a separateexit path 44 a, 44 b, such that the thrombin and the adhesive andclotting proteins may exit separately as lines or dots from ports 46 a,46 b in the outlet coupling 40, thereby preventing clogging of theoutlet coupling 40. A recessed threaded area 48 is located proximate theports 46 a, 46 b of the outlet coupling 40 to support a dispensingattachment.

[0056] The recessed female threaded area 48 of the outlet coupling 40may receive any of a variety of dispensing attachments having a threadedend 49; examples of attachments are shown in FIGS. 16-21, 23-27. Thespray nozzle 50 shown in FIGS. 23, 24 may be combined with lengtheningattachments, shown in FIGS. 25-27. These lengthening attachments arepreferably constructed with an external cylindrical shroud 63 whichoverlies intermediate sleeves 65 that support a central internal helicalpath 54 to enhance admixture of the thrombin and the adhesive clottingproteins. Mixing of the thrombin with the adhesive and clotting proteinsoccurs within the chosen attachment and is dispensed out the spray end52 of the spray nozzle 50 for precise placement. The spray nozzle 50 iscomprised of a barrel 51 having tactile enhancing, longitudinallyextending peripheral ribs 53. The end 52 includes a flow diverter 55 anda restrictor orifice body 57 having an orifice 59. The body 57 ispress-fit into bore 61 of nozzle 50 or attached by other means.

[0057]FIG. 15 depicts a dispensing apparatus 60 adapted to receive thesyringe pair assembly 20. In this embodiment, the outlet coupling 40connects to the dispensing apparatus 60 by registering a clasp 42present on the underside of the outlet coupling 40 with a pivot 62 (FIG.15). The syringe pair assembly 20 is inserted into the outlet coupling40 and the frame 24 is removed.

[0058]FIGS. 28, 29 depict a heating apparatus 70, which includes aplurality of elongated arctuate indentations 72, each shaped withprojecting saddles 73 to receive a syringe pair assembly 20 and toensconce a large portion of each syringe's barrel. The heating apparatus70 contains resistive heating elements 74 to maintain the assemblies 20at a constant temperature for heat transfer through indentations 72 andsaddles 73. The power cord 76 is connected to a power supply 78, whichin turn plugs into an electrical supply outlet. A sensor andmicrocontroller 76 optimize temperature. Compatible dispensingassemblies include, but are not limited to, the spraying apparatus 60 ofFIG. 15 and the basic syringe setup depicted in FIGS. 20, 21. Thus, theprepared biological glue is readily available for use during the medicalprocedure.

[0059] Moreover, having thus described the invention, it should beapparent that numerous structural modifications and adaptations may beresorted to without departing from the scope and fair meaning of theinstant invention as set forth hereinabove and as described hereinbelowby the claims.

I claim: 1- An apparatus for collecting thrombin and clotting proteins,comprising, in combination: a first conduit operatively connected to asource of thrombin; and a second conduit operatively connected to asource of clotting proteins, each said conduit operatively connected toa plurality of dispensing means. 2- The apparatus of claim 1 whereinsaid dispensing means are clustered in pairs, with one of each said pairreceiving thrombin and the other receiving clotting proteins. 3- Theapparatus of claim 2 wherein each pair is ensconced in a membrane. 4-The apparatus of claim 3 wherein said dispensing means are equipped witha removable fitting for connection to each said conduit. 5- Theapparatus of claim 4 wherein said membrane opens at an end opposite saidconduits, whereby removal or adjustment of said dispensing means mayoccur. 6- The apparatus of claim 5 wherein said membrane includes agathered portion of accordion folds, whereby expansion of saiddispensing means causes said gathered portion of accordion folds tounfold. 7- The apparatus of claim 6 wherein each said pair is heldtogether by a frame, said frame including a retaining member. 8- Theapparatus of claim 7 wherein said dispensing means are received byspraying means, said spraying means having means for simultaneousdelivery of the thrombin and clotting proteins. 9- The apparatus ofclaim 8 wherein a plurality of said dispensing means in said sprayingmeans are received by heating means, whereby contents of said dispensingmeans are maintained at a desired temperature until dispensed. 10- Theapparatus of claim 7 wherein a plurality of said dispensing means arereceived by heating means, whereby contents of said dispensing means aremaintained at a desired temperature until dispensed. 11- A method forloading dispensing means with thrombin and clotting proteins, the stepsincluding: attaching a plurality of said dispensing means to separatedispensing lines containing thrombin and clotting proteins; manipulatingsaid plurality of dispensing means to purge air in each of saiddispensing lines; and sequentially filling said plurality of dispensingmeans through each of said dispensing lines.